NCT00859027

Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Male
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

Detailed description

A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	risedronate	35 mg/week by mouth
DRUG	Placebo risedronate oral tablet	One tablet by mouth every week as directed

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-03-01
• Completion: 2009-02-01
• First posted: 2009-03-10
• Last updated: 2018-05-01
• Results posted: 2013-08-01

Locations

1 site across 1 country: United States